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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028805
Receipt No. R000032933
Scientific Title Single arm prospective observational study for severe heart failure patients repeating hospitalization (multicenter study)
Date of disclosure of the study information 2017/08/25
Last modified on 2019/02/25

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Basic information
Public title Single arm prospective observational study for severe heart failure patients repeating hospitalization (multicenter study)
Acronym Single arm prospective study for severe HF patients repeating hospitalization
Scientific Title Single arm prospective observational study for severe heart failure patients repeating hospitalization (multicenter study)
Scientific Title:Acronym Single arm prospective study for severe HF patients repeating hospitalization
Region
Japan

Condition
Condition heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to analyze the characteristics of the change in vital signs before cardiac failure exacerbation obtained from a noninvasive chest attachment type device and a wireless sensor with communication tools.
Basic objectives2 Others
Basic objectives -Others Safety,Efficacy
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 1) Re-hospitalization caused by heart failure, all deaths during the study period(0.5 year).
Key secondary outcomes 1) An elevation to more than 1000pg/ml of B-type peptide during the study period.
2) The reason why patients dropped out.
3) An expression of adverse events.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients who hospitalized caused by severe heart failure within a year.
2) Patients classified NYHA II or III or IV.
3) Patients who agreed to participate in this research by themselves.
4) Patients who were over 20 years old when they agreed to participate in this research.
Key exclusion criteria 1) Patients who wear pace makers, ICD and CRT(D), or are supposed to wear them.
2) Patients who are valued as inappropriate by a doctor to participate in this research.
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichiro Kinugawa
Organization University of Toyama
Division name Second Department of Internal Medicine
Zip code
Address 2630 Sugitani, Toyama
TEL 076-434-7297
Email kinugawa-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuji Joho
Organization University of Toyama
Division name Second Department of Internal Medicine
Zip code
Address 2630 Sugitani, Toyama
TEL 076-434-7297
Homepage URL
Email sjoho@med.u-toyama.ac.jp

Sponsor
Institute 1) University of Toyama
2) Tokyo Metropolitan Geriatric Hospital
Institute
Department

Funding Source
Organization Secom Science and Technology Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Tokyo Metropolitan Geriatric Hospital, SECOM Medical System CO.,LTD.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 富山大学附属病院(富山県)、東京大学医学部附属病院(東京都)、東京都健康長寿医療センター(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 30 Day
Last follow-up date
2018 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Data analysis in progress.

Management information
Registered date
2017 Year 08 Month 24 Day
Last modified on
2019 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032933

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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